UMIN-CTR Clinical Trial

Unique ID issued by UMIN	UMIN000002233
Receipt number	R000002636
Scientific Title	Comprehensive study of brain stiffness and brain viscoelasticity measured by tactile biosensor over the scalp
Date of disclosure of the study information	2009/07/22
Last modified on	2014/06/25 09:34:48

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Basic information

Public title

Comprehensive study of brain stiffness and brain viscoelasticity measured by tactile biosensor over the scalp

Acronym

Brain stiffness over the scalp

Scientific Title

Comprehensive study of brain stiffness and brain viscoelasticity measured by tactile biosensor over the scalp

Scientific Title:Acronym

Brain stiffness over the scalp

Region

Japan

Condition

inpatient who underwent decompressive craniectomy

Classification by specialty

Neurosurgery

Classification by malignancy

Others

Genomic information

Objectives

Narrative objectives1

The aim of this study was the quantification of brain stiffness using a tactile biosensor under the condition of increased intracranial pressure at the cranial decompressive site.

Basic objectives2

Others

Basic objectives -Others

We studied (1) the correlation between palpation of decompressive window and measurements of a tactile biosensor, (2) the usefulness of variables obtained from hysteresis curve measured by sensor, and (3) the correlation of several items related to degree of brain swelling.

Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable

Assessment

Primary outcomes

We measured the correlation between degree of palpation and viscoelastic value by tactile biosensor from immediate postoperative day to the day of cranioplasty.

Key secondary outcomes

We evaluated neurology and the brain swelling degree of head CT

Base

Study type

Observational

Study design

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

Intervention

No. of arms

Purpose of intervention

Type of intervention

Interventions/Control_1

Interventions/Control_2

Interventions/Control_3

Interventions/Control_4

Interventions/Control_5

Interventions/Control_6

Interventions/Control_7

Interventions/Control_8

Interventions/Control_9

Interventions/Control_10

Eligibility

Age-lower limit

Not applicable

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

inpatient who underwent decompressive craniectomy due to supratentrial increased intracranial pressure.

Key exclusion criteria

posterior fossa decompression, internal decompression of brain cortex, infection, and hemorrhagic tendency

Target sample size

Research contact person

Name of lead principal investigator

1st name

Middle name

Last name Hidemasa Nagai

Organization

Shimane University Faculty of Medicine

Division name

Department of Neurosurgery

Zip code

Address

Enya89-1, Izumo city Shimane

TEL

0853-20-2245

Email

Public contact

Name of contact person

1st name

Middle name

Last name Hidemasa Nagai

Organization

Shimane University Faculty of Medicine

Division name

Department of Neurosurgery

Zip code

Address

Enya89-1, Izumo city Shimane

TEL

0853-20-2245

Homepage URL

Email

h-nagai@shimane-med.ac.jp

Sponsor or person

Institute

Department of Neurosurgery Shimane University Faculty of Medicine

Institute

Department

Personal name

Funding Source

Organization

none

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Other related organizations

Co-sponsor

Name of secondary funder(s)

IRB Contact (For public release)

Organization

Address

Tel

Email

Secondary IDs

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Other administrative information

Date of disclosure of the study information

2009 Year 07 Month 22 Day

Related information

URL releasing protocol

http://www.surgicalneurologyint.com

Publication of results

Published

Result

URL related to results and publications

http://www.surgicalneurologyint.com

Number of participants that the trial has enrolled

Results

Background: Decompressive craniectomy is undertaken for relief of brain herniation caused by acute brain swelling. Brain stiffness can be estimated by palpating the decompressive cranial defect and can provide some relatively subjective information to the neurosurgeon to help guide care. The goal of the present study was to objectively evaluate transcutaneous stiffness of the cranial defect using a tactile resonance sensor and to describe the values in patients with a decompressive window in order to characterize the clinical association between brain edema and stiffness.
Methods: Data were prospectively collected from 13 of 37 patients who underwent a decompressive craniectomy in our hospital during a 5-year period. Transcutaneous stiffness was measured as change in frequency and as elastic modulus.
Results: Stiffness variables of the decompressive site were measured without
any adverse effect and subsequent calculations revealed change in frequency =101.71/36.42 Hz, and shear elastic modulus =1.99/1.11 kPa.
Conclusions: The elasticity of stiffness of a decompressive site correlated with
brain edema, cisternal cerebrospinal fluid pressure, and brain shift, all of which are related to acute brain edema.

Results date posted

Results Delayed

Results Delay Reason

Date of the first journal publication of results

Baseline Characteristics

Participant flow

Adverse events

Outcome measures

Plan to share IPD

IPD sharing Plan description

Progress

Recruitment status

Completed

Date of protocol fixation

2009 Year 06 Month 22 Day

Date of IRB

Anticipated trial start date

2009 Year 07 Month 01 Day

Last follow-up date

2014 Year 06 Month 22 Day

Date of closure to data entry

2014 Year 06 Month 23 Day

Date trial data considered complete

2014 Year 06 Month 24 Day

Date analysis concluded

2014 Year 06 Month 25 Day

Other

Other related information

Elastic modulus measured by spherical indentation used toward the clinical
application of the brain stiffness]. Brain Nerve. 2013,65(1):85-92. Japanese.

OBJECTIVE: Palpation of brain stiffness is one of techniques that leads to successful neurosurgical procedures. In order to evaluate brain stiffness quantitatively, we studied the potential clinical applicability of a spherical indenting tactile sensor.
METHODS: The sensor had a spherical rigid indenter (diameter=5.0 mm; contact pressure=1.0 gf/mm2), and the indenter was rapidly pushed and pulled at a constant speed by a computer-controlled motor. The pressure-depth hysteresis curve was obtained using the sensor, and the shear elastic modulus (G) was calculated on the basis of the Hertz contact theory. We adopted the G-value at the maximum depth (G_max) as an indicator of brain stiffness.
RESULTS: First, to calibrate the sensor, we investigated the elasticity of silicone plates. The optimal settings for clinical application was an indenting speed of 1.5 mm/s and an indenting maximum depth of 2-3 mm. Next, we measured the elasticity of a decompressive site in 7 patients who had been stable for more than 21 days after undergoing decompressive craniectomy. The G_max of the decompressive site was 1.71/0.75 kPa. Finally, we measured the intraoperative brain elasticity in a case of brain tumor with severe brain edema. The transdural elasticity of the edematous brain was G=4.87 kPa, and the direct elasticity of the brain surface decreased to G=4.34 kPa after dura incision.
CONCLUSIONS: The spherical indentation method for measuring brain elasticity seems applicable to neurosurgical procedures.

Management information

Registered date

2009 Year 07 Month 22 Day

Last modified on

2014 Year 06 Month 25 Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002636